The invention described herein relates to systems and methods for use in patient temperature control, and more specifically to devices employable for interconnecting a temperature control device such as a heating/cooling pad to a medical fluid processing apparatus.
The use of contact pad system for selectively cooling and/or heating bodily tissue is known. In such systems a fluid, (e.g. water or air), is circulated through one or more pads to affect surface to surface thermal energy exchange with a patient. One highly effective contact pad and related system is disclosed in U.S. Pat. No. 6,197,045, hereby incorporated by reference in its entirety. As noted in U.S. Pat. No. 6,197,045, the ability to establish and maintain intimate pad to patient contact is often key importance to fully realizing medical efficacies with contact pad systems.
Temperature management or thermal regulation can be viewed in two different ways. The first aspect of temperature management includes treating at normal body temperature (i.e. cooling the body for elevated temperatures or warming the body for lower temperature). The second aspect of thermal regulation is an evolving treatment that employs techniques that physically control a patient""s temperature to provide a physiological benefit, such as cooling a stroke patient to gain some degree of neuro protection.
In view of the foregoing, it may be appreciated that recognized medical applications for contact pad systems are ever increasing. By way of example, cooling pad systems may be utilized in early therapy to reduce neurological damage incurred by stroke and head trauma patients. Additional applications include selected patient heating/cooling during surgical procedure such as cardio pulmonary bypass operation.
As these and other medical applications have evolved, the present inventors have recognized the desirability of enhancing the flexibility and portability of thermal exchange fluid systems. More particularly, while heating/cooling contact pads systems have proven effective for many applications, the present inventors have recognized that additional performance and potential applications can be realized via implementation of further improved hose and connector device assemblies.
Disclosed herein is a system employable for providing patient temperature control which includes a medical fluid circulating system which includes at least one reservoir for circulating medical fluid. Included in the system is at least one first connector which is interconnected and/or interconnectable to a patient temperature control pad, wherein the first connector includes a body portion with a plurality of channels extending therethrough, as well as a connection end. Also included in this system is at least one second connector which is interconnected and/or interconnectable to the medical fluid circulating system wherein the second connector includes a body portion with a plurality of channels extending therethrough and a connection end configured to engage the connection end of the first connector so as to create a plurality of sealed fluid paths through the first and second connectors when engaged. The first and second connectors are further configured to include at least one orientation device such that the first end second connectors are connectable at only a predetermined orientation.
In one configuration of the invention, the first connector may be configured as a male connector end with an insertion end configured in the body portion. The second connector may be configured as a female connector further configured with a receiving end. The male and female connectors may be configured to include at least one orientation device employable to connect the male and female connectors at a desired relative orientation. The orientation devices employed in the male and female connectors may include an alignment flange positionable between openings in the insertion end of the male connector and an interference surface extending between the openings of the receiving end of the female connector such that upon attempting to interconnect the connectors at an orientation other than a predetermined orientation, the alignment flange and interference surface will come in contact, thus blocking insertion and interconnection.
In yet another configuration of the invention, the female connector may be configured with an engagement surface and the male connector may include an engagement device manipulable to engage and disengage the engagement surface of the female connector upon insertion in the receiving end. This engagement surface may be configured as a ledge structure incorporated into the body portion of the female connector.
The engagement device for the male connector may include at least one flex arm which extends substantially perpendicular from the body portion, as well as a latch arm connectable to the flex arm which is rotatable substantially about the connection point to the flex arm. Incorporated into the latch arm is an engagement portion configured to interlock with the engagement surface of the female connector. In yet another configuration of the invention, both the engagement portion of the first connector and the engagement surface of the second connector may be configured as interlocking lip structures.
The female connector assembly may be further configured to include at least one spring loaded valve device locatable within each of the channels which is configured to open upon insertion of the male connector in the channel and close upon its removal. An additional feature incorporated into the interlocking connectors is that once the insertion end of the male connector is within the female connector, the resistive force exerted by the valve spring on the insertion end of the male connector provides for maintaining contact between the engagement surface and engagement devices such that inadvertent disengagement of the connectors is substantially avoided.
In yet another configuration of the invention, the male connector includes a plurality of the engagement devices which require substantially simultaneous manipulation during the engagement and disengagement procedure. In particular, the male connector may be configured such that the insertion end of the male connector is not removable from the receiving end of the female connector until a further insertion force is exerted on the male connector further compressing the spring loaded valve device such that the interlocking lips are moved clear of each other. The plurality of engagement devices on the male connector are then simultaneously manipulated (such as with a thumb and finger) so as to clear the engagement surfaces. At this point, the insertion force is reversed and the male connector is removable.
In yet another configuration of the invention, the female connector may be further configured to include a rotatable engagement device in a receiving end and the male connector configured to include at least one engagement portion configured to receive the rotatable engagement device. Further, the male and female connectors may be configured such that at a first rotational orientation for the rotatable engagement device, the device will pass within the engagement portion of the male connector, and at a second rotational orientation the device will mechanically contact a portion of the male connector such that the male and female connectors are mechanically engaged.
The male connector may be further configured to be connectable and/or connected to a one piece hose section which includes a plurality of fluid channels formed therethrough. Still further, the one piece hose section may be connectable to at least one other connector. The other connector may be a female connector which includes one or more receiving ends for interconnecting with one or more male connectors which in turn are interconnected and/or interconnectable with a patient temperature control pad.
Further described herein is a system for circulating medical fluid through a temperature control pad wherein the system includes a female machine connector which is mountable on a medical fluid processing system. The female machine connector is further interconnected and/or interconnectable to a patient temperature control pad assembly which includes a male machine connector configured to connect with the female machine connector, a hose assembly, and the patient temperature control pad(s). Incorporated in the female machine connector is a receiving end which is configured to receive and fluidly seal with a male machine connector end insertable therein. The receiving end is further configured to include an engagement device, wherein the engagement device, while positionable within the receiving end, may pass within a portion of a male machine connector that is insertable in the receiving end. The engagement device is further configured to be manipulated such that the male and female machine connectors are mechanically engaged, and a plurality of sealed fluid paths are established.
As part of the system described herein the female machine connector may be further configured such that the engagement device includes a rotatable element which is configured to pass within the engagement portion of a male machine connector at a first rotational orientation and engage the male machine connector at a second rotational orientation. The rotatable engagement device may include shaft portion with a semi circular shape and the engagement portion of the male machine connector may be configured as a slot which opens into a cylindrical section. In operation, the engagement device, at a first profile relative to the male machine connector, may pass within the slot and into to the cylindrical portion, and then upon rotation to the second rotational orientation, have a profile which is too large for the slot portion thus contacting the internal surfaces of the cylindrical section and providing mechanical engagement between the male and female machine connectors. As an additional feature the position of engagement portion in the male machine connector may provide for interconnection of the male and female machine connectors only at a predetermined orientation.
As part of the temperature control pad assembly, the male machine connector may be further connected to a one piece hose section with a plurality of channels passing there through. The one piece hose section may be further connectable to an intermediate connector device which is also in fluid communication with the channels through the one piece hose section. The intermediate connector device may be further connectable to at least one other connector in the temperature control pad assembly. In one configuration of the invention, the intermediate connector device may be configured as a female intermediate connector connectable with one or more male intermediate connectors.
The male intermediate connectors, which are part of the temperature control pad assembly, may include a body portion with a plurality of fluid channels extending therethrough, and an insertion end specially configured for passing within a portion of the female intermediate connector. The female intermediate connector is also configured with a plurality of fluid channels formed therethrough, and further includes at least one receiving end configured to receive an insertion end for the male intermediate connector(s). Incorporated into the external surfaces of both the intermediate connectors described herein may be at least one orientation device or surface employable to align the male and female intermediate connectors for interconnection purposes.
The orientation devices or surfaces may be incorporated in the body portion of the intermediate connectors such that the insertion end for the male intermediate connector and/or the receiving end of the female intermediate connector include at least one non-symmetrical feature. This non-symmetrical feature may comprise an alignment flange extending between the fluid channels on the male intermediate connector, and/or a member incorporated in the receiving end of the female intermediate connector which extends between two openings incorporated therein. In the situation where the male intermediate connector is inserted within the receiving end at an incorrect orientation, the alignment flange will contact the orientation surface, thus blocking insertion therein.
Further with regards to the male and female intermediate connectors, these devices may be further configured to include various external engagement surfaces and devices which maintain engagement during operation of the system described herein. In one configuration of the invention, the female intermediate connector may be configured with at least one engagement surface and the male connector configured with at least one engagement device manipulable to engage and disengage with the engagement surface of female connector upon insertion in the receiving end. The engagement surface of the female intermediate connector may be configured as a ledge incorporated into body. The engagement device incorporated in the male intermediate connector may include at least one flex arm extending substantially perpendicular from the body portion of the male intermediate connector, a latch arm positionable at an end of the at least one flex arm. The flex arm may be further configured to include an engagement portion whereby the engagement portion is rotatable about the flex arm portion through manipulation of the flex arm at a point opposite the engagement surface relative to the flex arm.
In employing the engagement devices described above, the female intermediate connector may be further configured with at least one spring loaded valve device locatable within the fluid channels which opens and closes depending on the insertion status of a male intermediate connector end. The engagement surface of the female intermediate connector may be configured to include an interlocking lip portion which is configured to receive an interlocking lip configured into the latch arm of the male intermediate connector. These interlocking lips are specially configured such that upon insertion of the male intermediate connector within the insertion end of the female intermediate connector, the valve springs of the internal valve device are compressed and upon releasing the male intermediate connector the springs uncompress thus pushing the interlocking lips together. The relative surfaces of these lips are configured such that they resist any lateral movement of the connector device and connector surface with regards to the body portions of the male and female intermediate connectors.
In yet another configuration of the invention, the male intermediate connector may include a plurality of the engagement devices which require substantially simultaneous manipulation during the engagement and disengagement procedure. In particular, the male intermediate connector may be configured such that the insertion end of the male intermediate connector is not removable from the receiving end of the female intermediate connector until a further insertion force is exerted on the male intermediate connector further compressing the spring loaded valve device such that the interlocking lips are moved clear of each other. The plurality of engagement devices on the male intermediate connector are then simultaneously manipulated (such as with a thumb and finger) so as to clear the engagement surfaces. At this point, the insertion force is reversed and the male intermediate connector is removable.